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INDICATIONS
The SIGMA High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.

The DePuy SIGMA® High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint.

The unicompartmental femoral components are Co-Cr-Mo metal implants, available with or without a porous coating. The metal backed tibial components are Co-Cr-Mo and polyethylene and are available without a porous coating. The all-polyethylene unicompartmental tibial component manufactured from polyethylene.

The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).

The provided text describes a 510(k) premarket notification for a medical device, the SIGMA High Performance (HP) Partial Knee System. While the document outlines information about the device itself and its equivalence to predicate devices, it does not contain the acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML-driven device's performance.

The document states:

• "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE": This lists a number of engineering and material tests (Biocompatibility, UHMWPE Material Property Characterization, Range of Motion/Constraint, Contact Area/Stress, Wear Testing, Pull-Off, Bacterial Endotoxin testing).
• "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION - Clinical testing was not necessary to demonstrate substantial equivalence."

This indicates that the submission is focused on demonstrating substantial equivalence based on material properties, design, and manufacturing processes, rather than the performance of an AI/ML algorithm. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not present in the provided text, as these are typically associated with the evaluation of AI/ML software performance.

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The NanoOrtho NanoKnee® System is indicated for restoring either compartment of a knee that has been affected by the following:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. Correction of femoral deformity;
3. Revision procedures where other treatments or devices have failed; and
4. Treatment of fractures that are unmanageable using other techniques.
   The NanoOrtho NanoKnee® System components are single use and are intended for implantation with or without bone cement.

The NanoOrtho NanoKne® is a unicompartmental knee system that includes porous coated and non-porous coated, cast CoCr, symmetric femoral components in sizes 1-6; and Ti6Al4V, symmetric, porous coated and non-porous coated tibial baseplate components in sizes 1-6. The tibial inserts are offered in standard UHMWPE, symmetric design, Constrained+, in sizes 1-6 and 5 thicknesses per size 9,10,11,12,14mm.

I apologize, but this document does not contain the specific information you requested regarding acceptance criteria and a study proving device performance.

The document is a 510(k) Premarket Notification from the FDA for the NanoOrtho NanoKnee® System. It focuses on establishing substantial equivalence to previously marketed devices (predicates) based on design features, materials, and indications for use.

While it mentions "Performance Testing" and lists several ASTM standards (e.g., ASTM F3140-17, ASTM F2083-12, ASTM F1223-14), these sections only state that "The results confirm that all components of the NanoOrtho NanoKnee® System are substantially equivalent to the predicate devices." It does not provide specific acceptance criteria, reported device performance values, sample sizes, ground truth establishment methods, or details about expert involvement or comparative effectiveness studies.

The document primarily states that the NanoOrtho NanoKnee® System is equivalent to predicate devices based on laboratory (bench) testing, but it does not detail the specific results, quantitative acceptance criteria, or the methodology of a "study" in the sense of clinical trials or AI performance evaluations.

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MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. inflammatory degenerative joint disease including rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

ADVANCE® 913 Medial Pivot Tibial Base and Insert Components (not licensed for sale in Canada) are for use with bone cement.

Porous-Coated Total Knee Replacement Components are for use without bone cement.

The EVOLUTION® Total Knee System is for cemented use only.

The subject devices for this submission are all the predicate devices listed above, which consists of implant components used in knee arthroplasty. The only changes to the subject devices are updates to their labeling. Specifically, the package inserts and package labels are being updated to include MR Conditional language and symbols. The subjects are identical to the predicates in all aspects except for the labeling updates. Testing is provided in this Traditional 510(k) that establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The basic design features are the following:

• Metal Femoral component manufactured from cobalt chrome alloy ●
• Femoral components available in porous and non porous versions
• Tibial inserts manufactured from UHMWPE
• Tibial bases manufactured from cobalt chrome alloy or titanium alloy ●
• Tibial bases available in porous and non porous versions ●
• All-poly patellae manufactured from UHMWPE
• Metal portion of metal backed patellae manufactured from titanium allov .

The provided text describes a 510(k) premarket notification for "MPO Total Knee Systems MR Labeling." This submission is solely for updating the labeling of existing total knee systems to include "MR Conditional" language and symbols, indicating their safety and compatibility in a magnetic resonance (MR) environment under specific conditions.

Therefore, the "device" in this context is not a new medical device whose performance is being evaluated in a clinical setting against acceptance criteria for diagnostic accuracy or treatment efficacy. Instead, the "device" is the existing knee implant system, and the study is focused on its MR compatibility, not its clinical performance or diagnostic capabilities.

Given this, the questions about acceptance criteria for device performance, sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable in their usual sense for a typical AI/diagnostic device submission.

However, I can extract information related to the MR compatibility testing:

1. Table of Acceptance Criteria and Reported Device Performance (for MR Compatibility)

Since the standard format of diagnostic accuracy or treatment efficacy performance is not relevant here, the acceptance criteria are related to meeting specific MR safety standards. The document doesn't explicitly list a "table" of acceptance criteria but states that testing was conducted according to specific ASTM standards. The "performance" is that the devices met these standards to be deemed "MR Conditional."

2. Sample size used for the test set and the data provenance:

• Sample Size: The document mentions "the worst case components and constructs" were evaluated for RF Heating, field interactions, and image artifacts. It does not provide a specific numerical sample size (e.g., number of individual implants tested). This is typical for bench testing where representative "worst-case" configurations are chosen rather than a large statistical sample of every single variation.
• Data Provenance: The testing was non-clinical (bench testing) and performed to recognized ASTM standards and FDA guidance. The "country of origin of the data" is not explicitly stated, but it would have been conducted by the manufacturer or a contracted lab to meet US FDA requirements. It is a prospective test in the sense that it was specifically conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. For MR compatibility bench testing, "ground truth" in the clinical diagnostic sense established by human experts is not relevant. The "ground truth" is determined by the physical measurements and observations made according to the defined test methods of the ASTM standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. Adjudication methods are for interpretation of clinical data or images, not for physical bench testing results. The results are objective measurements against specified thresholds in the standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI or diagnostic device. This is a knee implant system seeking MR conditional labeling. An MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable. The "ground truth" for MR compatibility testing is the objective physical measurements and observations obtained by following validated test methods (e.g., temperature changes, deflection angles, artifact size) as defined by the ASTM standards.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not Applicable. As there is no training set.

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The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:

· Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.

· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis.

· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

The RESTORIS ® Porous Femoral Component and PST® Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.

The RESTORIS® Porous Partial Knee System is a knee joint femorotibial (unicompartmental) prosthesis. The RESTORIS® Porous Partial Knee System consists of femoral components and tibial baseplate components that are compatible with and intended for use with MAKO's predicate RESTORIS MCK Tibial Onlay Insert Components (K090763 or K133039).

The RESTORIS® Porous Femoral Component and PST® Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.

The Porous Femur components: sizes 1 through 8, CoCr with a CoCr porous coating for cementless fixation, asymmetric design (meaning that left medial implants can be used on the right lateral compartment and right medial implants can be used on the left lateral compartment; abbreviated hereafter as LM/RL and RM/LL)

PST® Tibial Baseplate components: sizes 1 through 8. Ti6Al4V allov with MAKO's predicate porous surface (porous structured technology, referred to as "PST®"), asymmetric (LM/RL-RM/LL).

The provided document is a 510(k) premarket notification for a medical device, the RESTORIS® Porous Partial Knee System. It focuses on demonstrating substantial equivalence to a predicate device based on manufacturing materials, design, technological characteristics, and performance data.

However, this document does not contain the information requested regarding acceptance criteria and the study proving a device meets them in the context of AI/ML performance. The device described is a physical knee implant, not an AI-powered diagnostic or therapeutic tool.

Therefore, I cannot extract the following information from this document:

1. A table of acceptance criteria and the reported device performance: This document reports on non-clinical performance testing for a physical implant (e.g., snaplock strength, micromotion, wear), not AI model metrics like sensitivity, specificity, or AUC.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical implant, not an AI-assisted diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to physical implant performance testing in this context.
8. The sample size for the training set: Not applicable (no AI model).
9. How the ground truth for the training set was established: Not applicable (no AI model).

The "Performance Data" section lists non-clinical performance testing related to the physical characteristics and function of the knee implant, such as:

• Insert Snaplock Strength
• Tibial Insert / Baseplate Micromotion
• Tibio-Femoral Range of Motion
• Tibio-Femoral Instability
• Tibio-Femoral Contact Area and Stress
• Tibial Insert Fatigue
• Tibial Insert Wear

The conclusion states that "The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices." This is the general "acceptance" for a 510(k) submission for this type of device, demonstrating it functions as intended and is as safe and effective as a legally marketed predicate. However, detailed, quantitative acceptance criteria for each test (e.g., "snaplock strength > X N") are not provided in this summary, nor are the specific results for each test.

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Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment.

The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement.

The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement.

The Oxford Fixed Lateral Bearing Partial Knee Replacement is a partial knee replacement option that consists of a femoral component (single and twin peg versions) manufactured from CoCrMo (ASTM F-75), a tibial tray/plate manufactured from CoCrMo (ASTM F-75), and a fixed tibial bearing of direct compression molded (DCM) polyethylene (UHMWPE) conforming to ASTM F-648 which is molded onto the tibial tray.

The document is a 510(k) Summary for the Oxford® Fixed Lateral Bearing Partial Knee Replacement, seeking substantial equivalence to a previously cleared device (K122277). The modification is a design change to add a chamfer to the anterior corner of the tibial bearing, resulting in asymmetric left and right configurations.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance measures. Instead, the "performance data" section focuses on demonstrating substantial equivalence through non-clinical testing. The conclusion reached is that the subject construct is "substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

The document states "Non-clinical performance testing included cadaver evaluation and MRI justification."

• Sample Size for Test Set: Not explicitly stated as a number of samples or subjects. It only mentions "cadaver evaluation," implying a limited set of cadaver knees were used.
• Data Provenance: The cadaver evaluation would be considered prospective data collection for the specific purpose of this evaluation. The country of origin for the cadavers is not specified. MRI justification likely refers to engineering analysis or imaging studies to demonstrate the design change.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given it's a cadaver evaluation for a mechanical device modification, formal clinical adjudication methods like 2+1 or 3+1 are unlikely to have been employed in the same way they would for diagnostic imaging studies. The evaluation would likely have been conducted by biomechanical engineers or orthopedic surgeons.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? No. The product is a knee implant, not a diagnostic imaging AI algorithm that would typically undergo MRMC studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done? Not applicable. This is a physical medical device (knee implant), not an AI algorithm. The performance evaluation focuses on the mechanical and functional aspects of the implant itself, primarily through non-clinical testing.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device modification is established through physical and mechanical evaluation (cadaver evaluation), engineering justification, and comparison to the safety and effectiveness profile of the legally marketed predicate device. The goal is to show the modified device functions as intended without introducing new safety or effectiveness concerns, akin to demonstrating physical equivalence.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm that requires a training set in the conventional sense. The "training" for the design comes from extensive biomechanical and materials science knowledge, as well as experience with the predicate device.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Was Established: Not applicable. See point 8. The design process for a physical device relies on established engineering principles, material properties, biomechanical considerations, and clinical experience with similar devices, rather than a "ground truth" derived from a specific "training set" of data.

In summary: This document pertains to a 510(k) submission for a physical medical device (a knee implant modification), not a software or AI-driven diagnostic device. Therefore, many of the typical acceptance criteria and study components relevant to AI/software performance (like human reader studies, training/test sets, expert adjudication for image interpretation) are not applicable or described in this type of submission. The focus is on demonstrating "substantial equivalence" through non-clinical (cadaver and engineering) testing to a predicate device.

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The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.

The UNIVATION® Unicompartmental Knee System is a prosthesis that replaces only one compartment of the knee condyle which consists of a femoral, tibial and meniscal components that are available in a wide range of sizes. The UNIVATION® Unicompartmental Knee System components are medial unicondylar knee replacements for either the right or left knee. The femoral and tibial components are manufactured from CoCrMo, the meniscal components are manufactured from UHMWPE. The femoral and tibial components are available with either a PMMA (polymethylmethacrylate) or ZrN (Zirconium nitride) coating. All components are sterile and for single use only.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided document describes a UNIVATION® Unicompartmental Knee System, which is a medical device, and the information is from a 510(k) summary, likely for FDA clearance. This type of document focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving efficacy or diagnostic accuracy through clinical studies in the way an AI or diagnostic device would.

Therefore, many of the requested categories for acceptance criteria and study details (especially those related to AI, human readers, ground truth establishment, training sets, etc.) are not applicable to this type of device and its submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable/Specified. For this type of orthopedic implant, "test set" typically refers to the physical samples of the modified components used in the mechanical/endurance testing, not a dataset of patient images or clinical outcomes. The document states "customized endurance testing" was used, implying a certain number of physical components were tested, but the exact count is not provided.
• Data Provenance: Not applicable in the context of clinical/patient data. The "data" here comes from mechanical/endurance laboratory testing of the device components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not applicable. "Ground truth" in this context is established by the physical properties and performance metrics defined by the ISO and ASTM standards (e.g., deflection, fatigue life, failure modes). Experts (engineers, materials scientists) are involved in designing and conducting the tests, but it's not a "consensus-based ground truth" on clinical observations.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of clinical data (e.g., radiology images). This submission relies on objective mechanical engineering performance testing against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, not applicable. MRMC studies are used for diagnostic imaging devices to assess how AI affects human reader performance. This device is an orthopedic implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, not applicable. This device is an implant, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance Standards. The "ground truth" for the performance of the modified components is their ability to withstand defined stress/load cycles (5 million cycles for femur, 10 million cycles for tibia) without failure or exhibiting similar performance characteristics to the predicate device, as specified by ISO 14879-1:2000 and ASTM F1800-07 standards.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI algorithm for this device submission.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. (See #8)

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study conducted was a mechanical/endurance testing program focused on the design modifications made to the femur and tibia components of the UNIVATION® Unicompartmental Knee System.

• Purpose: To evaluate the bone interface geometry of the modified components and demonstrate that their performance characteristics are similar to the previously cleared predicate device (K081293). This was done to address potential risks identified in a risk analysis of the design changes.
• Methodology:
  • Femur Component: Customized endurance testing based on ISO 14879-1:2000.
  • Tibia Component: Customized endurance testing based on ASTM F1800-07.
• Test Duration/Cycles:
  • Femur: 5 million load cycles.
  • Tibia: 10 million load cycles.
• Results: "The results were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System." This indicates that the modified components performed equivalently to the predicate under the specified mechanical stress tests, thus meeting the key acceptance criteria for demonstrating substantial equivalence for the design changes.

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Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment.

The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement.

The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement.

The Oxford Fixed Lateral Bearing Partial Knee Replacement is a partial knee replacement option that consists of a legally marketed femoral component (single and twin peg versions) manufactured from CoCrMo (ASTM F-75), a tibial tray/plate manufactured from CoCrMo (ASTM F-75), and a fixed tibial bearing of direct compression molded (DCM) polyethylene (UHMWPE) conforming to ASTM F-648 which is molded onto the tibial tray. The femoral and tibial tray components have a coarse grit blast surface finish the same as that of the predicates. The tibial component (metal tray plus polyethylene) will be available in 6 sizes (A, B, C, D, E and F) and 5 overall thicknesses (8.0, 9.0, 10.0, 11.0, 12.0mm). The subject tibial component is D-shaped. The subject device is indicated for lateral use only for cemented use fixation.

The Oxford Fixed Lateral Bearing Partial Knee Replacement is a partial knee replacement that was evaluated in a non-clinical study to demonstrate its substantial equivalence to predicate devices (K042093 and K011138).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of human subjects or a dataset. The evaluation was based on preclinical performance tests/engineering rationales. The document does not provide details on the sample sizes for these preclinical tests or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The evaluation was based on non-clinical engineering tests and comparison to existing predicate devices, not on a ground truth established by medical experts for a diagnostic or classification task.

4. Adjudication method for the test set

This information is not applicable as the evaluation was based on non-clinical engineering tests, not expert review of a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This device is a knee implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical knee implant, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by engineering rationales and physical performance testing according to established methods (e.g., ASTM standards for materials). The primary method for demonstrating equivalence was direct comparison of the new device's characteristics and performance in these tests to those of the legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable. The device is a physical knee implant, not an algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable.

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Signature™ Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Signature™ Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ M Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, and AGC™ Complete Knee system.

The Signature™ guides are intended for single use only.

The Signature™ Personalized Patient Care System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the placement of Biomet total and partial knee replacement components.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state the sample size for the test set. It mentions "cadaveric trials" for accuracy performance testing.

The data provenance is from cadaveric trials, which implies a pre-clinical, non-human source. The country of origin is not specified. It is a retrospective study in the sense that cadavers are used for testing, but given the nature of the device (surgical planning and guidance), it implies a pre-clinical evaluation phase.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The provided text does not specify the number of experts used to establish ground truth or their qualifications for the test set.

4. Adjudication Method for the Test Set

The provided text does not specify an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance data focuses on the device's standalone accuracy and performance, not on its impact on human reader performance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done for the algorithm. The text states: "The Signature™ Planner software has been validated for its intended use to determine substantial equivalence to the predicate devices." and "...accuracy performance testing by means of cadaveric trials...was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended." This indicates the software and guides were tested for their inherent accuracy and performance.

7. Type of Ground Truth Used

The ground truth for the in-vitro performance was established through cadaveric trials for the surgical guidance accuracy. For the software validation, it's implicitly against established engineering and computational standards for accuracy, though the exact method isn't detailed.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set. The device description points to it being a software that generates plans based on MRI imaging data, implying an underlying algorithm that would likely have been trained, but no details are given.

9. How the Ground Truth for the Training Set Was Established

The provided text does not describe how the ground truth for the training set was established.

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The EVOLUTION™ Unicondylar Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. correction of functional deformity;
3. revision procedures where other treatments or devices have failed: and treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION™ Unicondylar Knee System is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
   The EVOLUTION™ Unicondylar Knee System is for cemented use only.

The design features of the EVOLUTION™ Unicondylar Knee System are summarized below:

• Femoral components manufactured from Cobalt Chrome Alloy
• Femoral component sizes 1 5, Resurfacing- or Resection-based .
• Tibial inserts manufactured from UHMWPE
• Tibial insert: Universal, sizes 1 - 5
• Tibial insert: Conforming, sizes 1 5, left and right .
• Tibial component thickness: 8, 9, 10, 11, 12mm
• Tibial bases manufactured from Titanium Alloy
• Tibial base sizes 1 – 5, left and right
• All-poly tibial components manufactured from UHMWPE
• All-poly Universal: sizes 1 - 5, left and right
• All-poly Conforming: sizes 1 - 5, left and right
• All-poly tibial component thickness: 7, 8, 9, 10, 11, 12mm
  The EVOLUTION™ Unicondylar Knee System was evaluated via mechanical testing and engineering analyses; including static stability, contact area, lock detail, femoral component strength, range of motion, and wear testing. A review of these results indicates that the EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

The provided text describes a 510(k) premarket notification for the "EVOLUTION™ Unicondylar Knee System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through a new clinical effectiveness study.

Therefore, the document does not contain information about explicit acceptance criteria and a study designed to prove the device meets those criteria in the way envisioned by the posed questions (e.g., performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance).

Instead, the "study" demonstrating the device's acceptability is based on showing equivalence to existing devices through mechanical testing and engineering analyses, along with a comparison of design features and materials.

Here's a breakdown based on the provided text, addressing the questions where applicable and explaining why certain information is not present:

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criteria (Implied)	Reported Device Performance
   Functional equivalence to predicate devices.	"The EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices"
   Capability of withstanding expected in vivo loading without failure.	"capable of withstanding expected in vivo loading without failure"
   Safety and effectiveness supported by substantial equivalence.	"The safety and effectiveness of the EVOLUTION™ Unicondylar Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."
   Indications for use identical to previously cleared predicate devices.	"The indications for use of the EVOLUTION™ Unicondylar Knee System are identical to the previously cleared predicate devices."
   Design features and materials substantially equivalent to predicate devices.	"The design features and materials of the subject devices are substantially equivalent to those of the predicate devices."
   Fundamental scientific technology unchanged relative to predicate devices.	"The fundamental scientific technology of the modified devices has not changed relative to the predicate devices."

   Note: The "acceptance criteria" here are implied by the 510(k) process, which is about demonstrating substantial equivalence, not setting and meeting novel performance thresholds. The "reported device performance" directly addresses these equivalence claims.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This information is not applicable/not provided because the submission relies on mechanical testing, engineering analyses, and comparison to predicate devices, not a clinical "test set" of patients with discrete performance metrics.
   • The "study" here is primarily a comparison document and technical report, not a clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This information is not applicable/not provided. Ground truth in the context of a clinical test set is not relevant for this type of submission. The "ground truth" for demonstrating equivalence largely lies in technical specifications, material properties, and mechanical test results, assessed by engineers and regulatory bodies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not applicable/not provided. There was no clinical "test set" requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This information is not applicable/not provided. This is a medical device (knee implant) submission, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • This information is not applicable/not provided. Not an AI or software device. Performance is assessed through mechanical testing and equivalence, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" in this context is the established safety and effectiveness of the predicate devices, as well as accepted engineering principles, material science standards, and mechanical testing results. The submission argues that because the new device's design, materials, and mechanical performance are equivalent to these established devices, it also shares their safety and effectiveness profile.

8. The sample size for the training set:

   • This information is not applicable/not provided. There is no "training set" in the context of an implantable medical device submission based on substantial equivalence.

9. How the ground truth for the training set was established:

   • This information is not applicable/not provided. See point 8.

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The Stryker® Compartmental Knee System Line Extension consists of sterile, single-usc devices intended for replacement of the patellofemoral joint and/or the condyle region(s) of the femoral joint as needed. The Stryker® Compartmental Knee System Line Extension includes Triathlon® PKR femoral condyle regions for cither the right or left knee.

The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or unicondylar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different components of the Stryker® Compartmental Knee System include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the following conditions:

• . Degenerative arthritis in the distal femur and patella.
• Patients with a history of patellar dislocation or patella fracture, .
• . Patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists,
• . Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
• . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knec prosthesis,
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, . or
• Where bone stock is of poor quality or inadequate for other reconstructive techniques . as indicated by deficiencies of the femoral condvle/tibial plateau.

These components are single use only and are intended for implantation with bone cement only.

The Stryker® Compartmental Knee System consists of sterile, single-use components intended for replacement of the femoral side of the patellofemoral joint and/or the condyle region(s) of the femoral joint as needed. The system includes patellofemoral, femoral, and tibial components from currently marketed Howmedica Ostconics' knee systems for patellofemoral and unicondylar arthroplasty. The system allows the physician to choose the most appropriate option to treat the patient with patellofemoral arthroplasty and/or unicondylar arthroplasty as needed.

The provided document, K082567, is a 510(k) premarket notification for the Stryker® Compartmental Knee System Line Extension. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials to prove device performance against specific acceptance criteria. Therefore, the document does not contain information related to acceptance criteria or studies providing device performance metrics in the way one might expect for a new, novel device seeking de novo clearance or requiring a PMA.

Instead, the "study" described is an "analysis" demonstrating substantial equivalence, which primarily focuses on comparing the new device to existing predicate devices based on design, materials, and intended use.

Here's an breakdown of the requested information based on the provided text, and where the requested information is not applicable or not present in a 510(k) submission of this nature:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not Applicable. There was no "test set" in the context of a new clinical study for this 510(k) submission.
• Data Provenance: Not Applicable. This submission primarily relies on a comparison to existing predicate devices and their known performance, rather than new data generated from a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not Applicable. No new ground truth was established by experts for a test set as part of this 510(k) submission. Substantial equivalence relies on the established safety and effectiveness of predicate devices, which would have undergone their own regulatory evaluations.
• Qualifications of Experts: Not Applicable.

4. Adjudication method for the test set

• Adjudication Method: Not Applicable. There was no test set or adjudication process described as part of this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Comparative Effectiveness Study: No. This is a knee prosthesis, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is entirely irrelevant to this device.
• Effect Size: Not Applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: No. This is a physical knee prosthesis, not an algorithm or AI device.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for a 510(k) submission for a device like this is the established safety and efficacy of the legally marketed predicate devices. The new device is deemed "substantially equivalent" if it shares similar technological characteristics and intended use, and raises no new questions of safety or effectiveness compared to the predicates.

8. The sample size for the training set

• Sample Size for Training Set: Not Applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not Applicable.

Summary of the "Study" for Substantial Equivalence:

The "study" or evidence provided is an analysis of substantial equivalence. The document states:

"The device is substantially equivalent to its predicates for patellofemoral arthroplasty and femorotibial arthroplasty in regards to intended use, design, materials, and operational principles. The analysis demonstrated that the components from these systems are compatible when used for patellofemoral and/or femorotibial replacement."

This means Stryker compared the new "Compartmental Knee System Line Extension" to previously cleared predicate devices, demonstrating that its features (design, materials, intended use, and how it works) are similar enough to those predicates that it doesn't raise any new safety or effectiveness concerns. The FDA agreed with this assessment, issuing the 510(k) clearance based on this demonstration of substantial equivalence.

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